Ortho Result Plus/Rubella Rapid Color. Immunoassay
FDA 510(k) K884617 · Ortho Diagnostic Systems, Inc.
510(k) numberK884617
Submission
- Device name
- Ortho Result Plus/Rubella Rapid Color. Immunoassay
- Applicant
- Ortho Diagnostic Systems, Inc.
Raritan, NJ, US - Received
- November 4, 1988
- Decision date
- February 2, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LFX – Enzyme Linked Immunoabsorbent Assay, Rubella
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3510
- Specialty
- Microbiology
Other 510(k)s with product code LFX
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|---|---|---|---|
| K250588 | Access Rubella IgGLFX · Traditional | Beckman Coulter, Inc. | 11/17/2025SE |
| K243168 | Alinity i Rubella IgGLFX · Traditional | Abbott Laboratories | 06/20/2025SE |
| K122397 | Liaison Rubella Igm, Liaison Control Rubella IgmLFX · Traditional | DiaSorin, Inc. | 09/06/2012SE |
| K093101 | Mago 4SLFX · Traditional | Diamedix Corp. | 01/21/2011SE |
| K092587 | Bioplex 2200 Rubella & CMV Igm Kit on the Bioplex 2200 Multi Analyte Detection SystemLFX · Traditional | Bio-Rad Laboratories | 12/03/2010SE |
| K092322 | Elecsys Rubella Igm ImmunoassayLFX · Traditional | Roche Diagnostics | 03/12/2010SE |
| K080766 | Vidas Rub IggLFX · Traditional | bioMerieux, Inc. | 12/23/2008SE |
| K072617 | Elecsys Rubella Igg ImmunoassayLFX · Traditional | Roche Diagnostics Corp. | 12/05/2008SE |
| K073390 | Diasorin Liason Rubella Igg Assay; Diasorin Liaison Rubella Igg Tri-ControlsLFX · Traditional | DiaSorin, Inc. | 11/21/2008SE |
| K063186 | Athena Multi-Lyte Rubella Igg Test SystemLFX · Traditional | Zeus Scientific, Inc. | 03/21/2007SE |
More from Zeus Scientific, Inc.
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| K951459 | Ortho-Mune Okt 4A (CD4) - Monoclonal Antibody (Murine) Fitc ConjugateGKZ · Traditional | 07/14/1997SE |
| K951632 | Ortho-Mune Ok-Combo Control IGG2A-FITC/IGG2A-PE Monoclonal Antibody (Murine)GKZ · Traditional | 03/06/1997SE |
| K964754 | Ortho-Mune Okb (CD19)- Monoclonal Antibody (Murine) Phycoerythrine ConjugateGKZ · Traditional | 01/22/1997SE |
| K963902 | Quantitative Fibrinogen AssayGIS · Traditional | 11/29/1996SE |
| K951100 | Ortho-Mune Ok-Combo CD3-FITC/CD19-PE (OKT3/OKB19A Monolclonal Antibody (Murine)GKZ · Traditional | 05/13/1996SE |
| K950625 | Ortho-Mune Ok-Combo CD40FITC/CD8-PE (OKT4A/OKT8) Monoclonal Antibody (Murine)GKZ · Traditional | 05/13/1996SE |
| K950568 | Ortho-Mune Ok-Combo CD3-FITC/CD4-PE (OKT2/OKT4A) Monoclonal Antibody (Murine)GKZ · Traditional | 05/13/1996SE |
| K950482 | Ortho-Mune Ok-Comvo CD3-FITC/CD8-PE (Okt 3/OKT8) Monoclonal Antibody (Murine)GKZ · Traditional | 05/10/1996SE |
| K935720 | Ortho Count Calibration Kit for Ortho Cytoronabsolute Laser Flow Cytometry SystemGKZ · Traditional | 05/09/1996SE |
| K954570 | Ortho Immunocount Flow Cytometry SystemGKZ · Traditional | 04/30/1996SE |
Questions and answers
When was Ortho Result Plus/Rubella Rapid Color. Immunoassay cleared by the FDA?
Ortho Result Plus/Rubella Rapid Color. Immunoassay (K884617) received a 510(k) decision of Substantially Equivalent on February 2, 1989, 90 days after the submission was received.
What is the product code of K884617?
The FDA product code is LFX – Enzyme Linked Immunoabsorbent Assay, Rubella, a Class II (moderate risk) device regulated under 21 CFR 866.3510.